BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TALENT THORACIC STENT GRAFT SYSTEM - XCELERANT

    MDR report key: 1905363 · Received November 18, 2010

    Report

    Report Number
    2953200-2010-02277
    Event Type
    Injury
    Date Received
    November 18, 2010
    Date of Event
    October 21, 2010
    Report Date
    October 21, 2010
    Manufacturer
    MEDTRONIC CARDIOVASCULAR
    Product Code
    MIH
    PMA / PMN Number
    P070007
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVAL, RESULTS, CONCLUSIONS: (FROM THE INFO PROVIDED, THE CAUSE OF THE MISALIGNED OPENINGS CANNOT BE DETERMINED).

    Description of Event or Problem · 1

    A TALENT THORACIC STENT GRAFT SYSTEM WAS IMPLANTED IN A PT FOR THE ENDOVASCULAR TREATMENT OF A THORACIC AORTIC ANEURYSM APPROX ONE MONTH AGO. THE AORTIC ARCH WAS NORMAL. AT THE SUBCLAVIAN ARTERY, THE DIAMETER OF THE THORACIC AORTA MEASURED 34-35 MM IN DIAMETER AND 1 CM DISTALLY IT WAS 38 MM IN DIAMETER. IT WAS REPORTED THAT WHEN DEPLOYMENT WAS INITIATED WITH THE FIRST THORACIC PROXIMAL MAIN, IT STARTED TO DEPLOY IN THE MISALIGNED POSITION, HOWEVER, THE PHYSICIAN PULLED THE DELIVERY SYSTEM DOWN AND CORRECTED THE MISALIGNED APEX. THE STENT GRAFT WAS IMPLANTED 2 CM LOWER THAN INTENDED. (MFR # 2953200-2010-02276). THE PHYSICIAN ELECTED TO IMPLANT A SECOND PROXIMAL MAIN STENT GRAFT AND DURING THE DEPLOYMENT, THE SAME THING THAT OCCURRED WITH THE FIRST DEVICE HAPPENED. A THIRD DEVICE WAS DEPLOYED AND LANDED AT THE INTENDED LOCATION. NO CLINICAL SEQUELAE WERE REPORTED AND THE PT IS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TALENT THORACIC STENT GRAFT SYSTEM - XCELERANT MIH MEDTRONIC CARDIOVASCULAR NA V00207215

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Required Intervention